FullField Digital Mammography Xray System 의 리콜

Recall

79078

Class 2

Z-0659-2018

2017-08-04

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161290

Fujifilm medical systems u.S.A., inc. (fmsu) identified a potential failure with our mammography system. the acquisition workstations, fdr¿1000aws, fdr-2000aws, fdr-3000aws, and cr¿ir363aws assign a unique id number to every image study but very rarely, with the acquisition workstation software versions, vs.O, vs.1, vs.2 , v6.0, v6.1, and v7.0, the system may assign the same id number to a new set of images that was already assigned to the previous set of images due to the error in id number generation logic. if an image with this error (with duplicate id number) is transmitted to pacs, it may overwrite the image already stored on pacs.

The firm, FUJIFILM Medical Systems U.S.A., Inc. (FMSU), sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 7/28/2017 to its customers. The letter described the products, problem and actions to be taken. The customers were instructed to please read and follow the instructions in the "ACTIONS TO BE TAKEN BY CUSTOMER/USER" section. If you have an error, contact your local FUJIFILM office; and complete and return the Customer Feedback Form. FUJIFILM service personnel will contact all of the medical facilities where the applicable products have been installed to arrange for this correction and visit to take corrective measures.. If you have any questions about this matter, call Recall contact (203) 276-3445 or email: dharaben.desai@fujifilm.com.